Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003610
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Capsaicin lozenges may be effective treatment for mucositis caused by radiation therapy It is not yet known whether capsaicin lozenges are more effective than no treatment for mucositis caused by radiation therapy
PURPOSE Randomized phase III trial to study the effectiveness of capsaicin lozenges in treating patients with mucositis caused by radiation therapy
PURPOSE Randomized phase III trial to study the effectiveness of capsaicin lozenges in treating patients with mucositis caused by radiation therapy
Detailed Description:
OBJECTIVES I Determine the efficacy of capsaicin lozenges in terms of frequency duration and severity of mouth pain caused by radiation therapy to the oral cavity II Evaluate the toxicity of this regimen in these patients
OUTLINE This is a randomized double blind placebo controlled study Patients are stratified according to dentures yes vs no smoking history none vs currently vs past only radiation therapy primary vs postoperative adjuvant planned radiation dose 5000-6000 cGy vs greater than 6000 cGy planned fluoride use yes vs no and amount of oral mucosa in radiation field one- to two-thirds vs greater than two-thirds Patients receive one lozenge orally of capsaicin or placebo four times daily Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed
OUTLINE This is a randomized double blind placebo controlled study Patients are stratified according to dentures yes vs no smoking history none vs currently vs past only radiation therapy primary vs postoperative adjuvant planned radiation dose 5000-6000 cGy vs greater than 6000 cGy planned fluoride use yes vs no and amount of oral mucosa in radiation field one- to two-thirds vs greater than two-thirds Patients receive one lozenge orally of capsaicin or placebo four times daily Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P98-0136 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066687 | REGISTRY | None | None |